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SMART Study: A Study of Re-treatment With MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on Anti-TNF Alfa Therapy

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01126541
First received: May 18, 2010
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

This study will compare the efficacy and safety of re-treatment with 2 doses of MabThera (rituximab) in patients with active rheumatoid arthritis (RA) who have previously experienced an inadequate response or intolerance to anti-tumor necrosis factor (anti-TNF) therapies etanercept, infliximab or adalimumab therapy. All patients will receive infusions of 1000 mg intravenous (IV) MabThera on Days 1 and 15; at Week 24 patients who have demonstrated a moderate or good response will be randomized to receive re-treatment with either 1 or 2 additional infusions of 1000 mg IV MabThera. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: rituximab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study to Assess the Effect of Retreatment With 2 Doses of MabThera on Disease Activity Score in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response or Intolerance to antiTNF-alfa Therapy.(SMART)

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Area under the curve (AUC) of the Disease Activity Score (DAS) [ Time Frame: From baseline up to Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: Quality of Life as measured by ACR 20/50/70, Eular response, change from baseline in SF-12, HAQ-DI, Pain VAS, Fatigue VAS, MOS score [ Time Frame: From baseline up to Month 24 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events (AEs) [ Time Frame: From baseline up to Month 24 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: September 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1000 mg IV rituximab
 Drug: rituximab
Arm A: 1000 mg IV (one infusion) every 2 months \nArm B: 2 x 1000 mg IV (2 infusions) every 2 months
Other Name: MabThera/Rituxan
Experimental: B
2 x 1000 mg IV rituximab
 Drug: rituximab
Arm A: 1000 mg IV (one infusion) every 2 months \nArm B: 2 x 1000 mg IV (2 infusions) every 2 months
Other Name: MabThera/Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients >18 years of age
  • RA for >=6 months
  • Receiving outpatient treatment
  • Ongoing treatment with methotrexate for >=3 months, stable for >=1 month
  • Inadequate response or intolerance to etanercept, infliximab or adalimumab

Exclusion Criteria:

  • Previous treatment with MabThera
  • Concurrent treatment with any anti TNF-alfa therapy or biologic therapy
  • Previous treatment with any investigational cell-depleting therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126541

  Show 52 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01126541     History of Changes
Other Study ID Numbers: ML19895
Study First Received: May 18, 2010
Last Updated: February 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 16, 2013